Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06007911
Phase
PHASE1
Status
Withdrawn

Conditions

  • Refractory AML
  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax Dose Level -1 — DRUG
    25 mg by mouth on days 1-7.
  • Navitoclax Dose Level 0 — DRUG
    50 mg by mouth on days 1-10.
  • Navitoclax Dose Level 1 — DRUG
    75 mg by mouth on days 1-10.
  • Navitoclax Dose Level 2 — DRUG
    100 mg by mouth on days 1-10.
  • Venetoclax Dose Level -1 — DRUG
    400 mg by mouth on days 1-7.
  • Venetoclax Dose Levels 0 to 2 — DRUG
    400 mg by mouth on days 1-14.
  • Cladribine — DRUG
    5 mg/m\^2 intravenously days 1-5.
  • Cytarabine (Cladribine Low Dose Cytarabine Backbone) — DRUG
    20 mg/m\^2 subcutaneous days 1-10.
  • Cytarabine (CLAG-M Backbone) — DRUG
    1.5 g/m\^2 intravenously days 1-5.
  • Mitoxantrone — DRUG
    10 mg/m\^2 intravenously days 1-3.
  • Granulocyte Colony-Stimulating Factor — DRUG
    300 mcg subcutaneously days 1-5.

Study Details

This is an open-label phase I study designed to evaluate the safety of venetoclax-navitoclax with cladribine-based salvage therapy.

Key Dates

Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level -1
    Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 0
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 1
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 2
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Maximum Tolerated Dose (MTD)
    The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.
  • Experimental: CLAG-M Backbone Level -1
    Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Level 0
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and granulocyte colony-stimulating factor (G-CSF).
  • Experimental: CLAG-M Backbone Level 1
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Level 2
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Maximum Tolerated Dose
    The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.

Primary Outcome Measure

Recommended Phase 2 Dose of Navitoclax for the Cladribine-Low Dose Cytarabine Backbone [ Time Frame: Up to three years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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